Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0234-2022 — Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venousfistulae and synthet

U.S. FDA — Device Enforcement · United States · 2021-09-20 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0234-2022
Date of alert: 2021-09-20
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Arrow International Inc
Product category: device
Product type: Devices

Reported risk: 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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